Senate passes hydrocodone rescheduling amendment

Final PDUFA bill could contain language to make all hydrocodone-containing products Schedule II; APhA signs letters to Senate, House opposing such language.

With language included on hydrocodone rescheduling that APhA opposes, the FDA Safety and Innovation Act (S. 3187) passed the U.S. Senate on May 24 with an amendment to reclassify all hydrocodone-containing products from Schedule III to Schedule II.

A companion bill passed the U.S. House of Representatives as the FDA Reform Act (H.R. 5651) on May 30 without language on hydrocodone rescheduling. The proposed hydrocodone reclassification is under consideration for the final bill to be sent by early summer to President Barack Obama, who is expected to sign the bill into law.

The pending legislation would reauthorize the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act, and start new user fee programs for generic drugs and biosimilars; it also includes language on drug shortages. For more information on PDUFA, see another article posted today on, “PDUFA legislation passes Senate, then House.”

Currently, while hydrocodone-only products are Schedule II, products combining hydrocodone with certain other drugs are Schedule III. Under a reclassification, patients would need an original prescription for refills, the products would be stored and transported more securely, and traffickers would be subject to increased fines and penalties. The Senate amendment would amend the Controlled Substances Act of 1970 to make any substance containing hydrocodone a Schedule II drug.

While prescription drug abuse and diversion are concerning and unfortunate, “these concerns must be balanced with the impact on patients who legitimately need access to these products,” according to May 30 letters to Senate and House offices signed by pharmacy groups including APhA, Food Marketing Institute, International Academy of Compounding Pharmacists, National Association of Chain Drug Stores, and National Community Pharmacists Association.

“There are numerous hydrocodone-containing combination products that patients need to treat moderate to severe pain from various conditions, such as cancer,” the pharmacy groups wrote. According to the letters, the Senate amendment is not needed because states can reclassify products as Schedule II without a change in federal law; products will be harder to obtain to treat pain; and burdens to pharmacies will increase, including “significantly higher administrative overhead costs to comply with additional secure storage, recordkeeping, and inventory management requirements.”

The letters were addressed to Sen. Joe Manchin (D-WV), who introduced the Senate amendment, and to Rep. Fred Upton (R-MI) and Rep. Henry Waxman (D-CA), Chair and Ranking Member respectively of the House Energy & Commerce Committee.

According to a May 24 news release from Manchin’s office, his measure—supported unanimously by the Senate—will fight addiction and abuse by making it harder to get addictive painkillers such a Vicodin and Lortab.

On May 30 on the House floor, Rep. Vern Buchanan (R-FL) gave a colloquy, saying, “I am pleased that the Senate FDA bill contains the central component of my bill,” Buchanan’s previous anti–pill mill legislation. Buchanan sought “to ensure that the final bill addresses this critical issue and contains the Buchanan pill mill provision.”

Upton responded, “When used properly, we know that these medications provide needed therapies for those suffering from pain. However, the abuse of some of those products has devastated communities and destroyed families across the country.” He continued, “So, as we move forward on this bill in our discussions with the Senate, I hope that we can … work this out.”